[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56770-56771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Food and Drug Administration/Xavier University Global Outsourcing 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in 
cosponsorship with Xavier University, is announcing a public conference 
entitled ``FDA/Xavier University Global Outsourcing Conference.'' This 
2.5-day public conference for the pharmaceutical industry is in direct 
alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes 
presentations from key FDA officials, global regulators, and industry 
experts. This conference drives collaboration on the topic of global 
outsourcing compliance by bringing pharmaceutical/biotechnology 
companies and contract partners to the same event to address the issues 
that reside on both sides of the contract. Expert presentations address 
the ``how to'' aspects of improving outsourced product quality through 
topics such as Strategic Procurement, End-to-End lifecycle product 
management, Managing Global Complex Supply Chains, and other topics. 
The experience level of our audience has fostered engaged dialog that 
has lead to innovative initiatives.
    Dates and Times: The public conference will be held on October 3, 
2011, from 8:30 a.m. to 5 p.m., October 4, 2011, from 8:30 a.m. to 5 
p.m., and October 5, 2011, from 8:30 a.m. to 1 p.m.
    Location: The public conference will be held on the campus of 
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
    Contact Persons:
    For information regarding this document: Steven Eastham, Food and 
Drug Administration, Cincinnati South Office, 36 East Seventh Street, 
Cincinnati, OH 45202, 513-246-4134, e-mail: [email protected].
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, e-mail: [email protected].
    Registration: There is a registration fee. The conference 
registration fees cover the cost of the presentations, training 
materials, receptions, breakfasts, lunches, dinners, and dinner 
speakers for the 2.5 days of the conference. Prior online registration 
or registration by mail must be done by October 3, 2011. There will 
also be onsite registration. The cost of registration is as follows:

                     Table 1--Registration Fees \1\
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                  Attendee                               Fee
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Industry...................................  $1,495
Small Business (<100 employees)............  1,000
Consultants................................  700
Startup Manufacturer.......................  300
Academic/Government........................  300
Media......................................  Free
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\1\ The fourth registration from the same company is free.

    The following forms of payment will be accepted: American Express, 
Visa, Mastercard, and company checks.
    To register online for the public conference, please visit the 
``Register Now'' link on the conference Web site at http://www.XavierGOC.com. FDA has verified the Web site address, but is not 
responsible for subsequent changes to

[[Page 56771]]

the Web site after this document publishes in the Federal Register.
    To register by mail, please send your name, title, firm name, 
address, telephone and fax numbers, e-mail, and payment information for 
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory 
Pkwy., Cincinnati, OH 45207. An e-mail will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarter hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West Fifth Street, Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue & 
Logistics'' link at http://www.XavierGOC.com. The hotel is expected to 
sell-out during this timeframe; so, early reservation in the conference 
room-block is encouraged.
    If you need special accommodations due to a disability, please 
contact Marla Phillips (see Contact Persons) at least 7 days in advance 
of the conference.

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the 
Department of Health and Human Services and FDA's important mission to 
protect the public health. The conference will provide those engaged in 
FDA-regulated outsourcing with information on the following topics:
     Regulatory Expectations for Outsourcing Roles and 
Responsibilities, Supply Chain Quality, and Challenges Observed,
     Price Versus Total Cost of Ownership,
     Strategic Procurement,
     Development and Commercial Contracts,
     Functional Quality Agreements,
     Meaningful Metrics,
     FDA and the Medicines and Healthcare Products Regulatory 
Agency Inspection Trends and Enforcement,
     McNeil Case Study and Living Under Consent Decree,
     Practical Risk Management and Case Studies of Litigation,
     Supplier Qualification Program,
     Third Party Initiatives and Impact,
     Operationalizing Quality-by-Design,
     Audit Panel to Cover Focus Areas for Due Diligence Audits, 
Ongoing Audit/Oversight, and Supply Chain Audits,
     The Power of Integrated Supply Chains--By Design. Drive to 
the Source of the Frustrations,
     End-to-End Planning for Successful Launch,
     Pharma Case Study on How to Manage a Global Complex Supply 
Chain,
     USP <1079>: Good Storage and Distribution Practices, and 
USP <1083> Pedigree and Track and Trace Presented By the Author, and
     Next Steps for the Industry.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The conference helps to achieve objectives set forth 
in section 406 of the Food and Drug Administration Modernization Act of 
1997 (21 U.S.C. 393), which includes working closely with stakeholders 
and maximizing the availability and clarity of information to 
stakeholders and the public. The conference also is consistent with the 
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 
104-121) by providing outreach activities by Government Agencies to 
small businesses.

    Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23482 Filed 9-13-11; 8:45 am]
BILLING CODE 4160-01-P